Clinical trial · Interventional
Clinical Utility Evidence for TissueCypher®
Establishing Clinical Utility Evidence to Support Coverage and Reimbursement for TissueCypher®: A CPV® Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Cernostics has developed a new diagnostic test, and this study will measure how gastroenterologists and foregut surgeons make diagnostic and treatment decisions when presented with different information in the context of simulated clinical cases. The results of this study could contribute to improved quality of care for patients by encouraging better care practices and adherence to evidence-based guidance. The data from this study will be provided to all participating physicians and submitted to a national journal for publication. The study plans to enroll up to 249 physicians.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett Esophagus | — | UNRESOLVED | — |
| Gastro-Intestinal Disorder | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Educational materials for TissueCypher | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Control Group
- description
- The control group does not receive educational materials about the TissueCypher diagnostic test and will treat their simulated patients with the current standard of care tools.
- type
- EXPERIMENTAL
- label
- Intervention Group 1
- description
- Intervention group 1 receives educational materials about the TissueCypher diagnostic test. These materials detail what the test does, how it is used, the validity and specifications of the test, and how to read its test report. This intervention group is then forced to use the test results in treating their simulated patients.
- interventionNames
- Other: Educational materials for TissueCypher
- type
- EXPERIMENTAL
- label
- Intervention Group 2
- description
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Board-certified gastroenterologist or GI surgeon for at least two years * Averages at least 20 hours per week of clinical and patient care duties over the last six months * performs either diagnostic endoscopy, interventional endoscopy, upper GI surgery, or bariatric surgery * practicing in the US * english speaking * access to the internet * informed and voluntarily consented to be in the study Exclusion Criteria: * non-English speaking * unable to access the internet * not practicing in the US * not averaging at least 20 hours per week of clinical or patient care duties over the last six months * does not perform either diagnostic endoscopy, interventional endoscopy, upper GI surgery, or bariatric surgery * does not voluntarily consent to be in the study
References
Publications (1)
- DERIVEDPeabody JW, Cruz JDC, Ganesan D, Paculdo D, Critchley-Thorne RJ, Wani S, Shaheen NJ. A Randomized Controlled Study on Clinical Adherence to Evidence-Based Guidelines in the Management of Simulated Patients With Barrett's Esophagus and the Clinical Utility of a Tissue Systems Pathology Test: Results From Q-TAB. Clin Transl Gastroenterol. 2024 Jan 1;15(1):e00644. doi: 10.14309/ctg.0000000000000644. PMID 37767993